D-0699-2020 Class II Terminated
FDA drug recall D-0699-2020 was initiated by Assurance Infusion on Dec 20, 2019 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated Oct 27, 2021). Affected quantity: 1 syringe.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 22, 2020
- Initiation Date
- Dec 20, 2019
- Termination Date
- Oct 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 syringe
Product Description
BUP 30MG/ FENT 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
Nationwide within the United States
Code Information
Lot: 12132019@3 Exp. 12/22/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0699-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026